CLINICAL TRIALS PROFILE FOR METHYLIN ER

All Clinical Trials for METHYLIN ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00754208 ↗	Long Acting Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Young Children	Completed	University of Nebraska	Phase 4	2008-10-01	This is a pilot study evaluating the effectiveness, safety, and tolerability of Ritalin LA in treating Attention Deficit Hyperactivity Disorder (ADHD) in 4 and 5 year old children. Virtually no data has been published on the use of long-acting stimulant preparations in very young children despite early symptomatic development in a significant portion of young children with ADHD. This would be one of the first studies looking at a long-acting preparation of a stimulant medication in the treatment of ADHD in very young children. Hypotheses 1. Ritalin LA is effective for the treatment of ADHD in 4 and 5 year old children. 2. Ritalin LA is reasonably well-tolerated in the treatment of ADHD in 4 and 5 year old children.
NCT01164956 ↗	Methylphenidate for Cancer-Related Fatigue	Terminated	Boston Children's Hospital	Phase 1	2011-07-01	The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the N-1-T design both for individual clinical decision making and for clinical trials in symptom management in pediatric oncology patients. Because no one knows which of the study options are best, participants will receive liquid MPH on some days and a placebo on other days. We will compare how the participant feels on MPH days with how they feel on placebo days to determine whether MPH makes a difference.
NCT01164956 ↗	Methylphenidate for Cancer-Related Fatigue	Terminated	Boston Children’s Hospital	Phase 1	2011-07-01	The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the N-1-T design both for individual clinical decision making and for clinical trials in symptom management in pediatric oncology patients. Because no one knows which of the study options are best, participants will receive liquid MPH on some days and a placebo on other days. We will compare how the participant feels on MPH days with how they feel on placebo days to determine whether MPH makes a difference.
NCT01164956 ↗	Methylphenidate for Cancer-Related Fatigue	Terminated	Dana-Farber Cancer Institute	Phase 1	2011-07-01	The overall aim of this pilot study is to conduct a combined N-of-1 trial (N-1-T) of MPH (methylphenidate) for amelioration of fatigue in children with cancer, and to evaluate the N-1-T design both for individual clinical decision making and for clinical trials in symptom management in pediatric oncology patients. Because no one knows which of the study options are best, participants will receive liquid MPH on some days and a placebo on other days. We will compare how the participant feels on MPH days with how they feel on placebo days to determine whether MPH makes a difference.
NCT02327195 ↗	General Anesthesia Emergence Induced by Methylphenidate	Completed	Nicoleta Stoicea	Phase 1	2014-05-01	The purpose of this study is to assess whether methylphenidate affects time of emergence from isoflurane general anesthesia. Time to emergence was defined as the time from termination of isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated and the time will be recorded.

Clinical Trial Conditions for METHYLIN ER

Condition Name

Condition Name for METHYLIN ER
Intervention	Trials
Attention Deficit Hyperactivity Disorder	1
Cancer	1
Delayed Emergence From Anesthesia	1

Condition MeSH

Condition MeSH for METHYLIN ER
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	1
Delayed Emergence from Anesthesia	1
Fatigue	1
Hyperkinesis	1

Clinical Trial Locations for METHYLIN ER

Trials by Country

Trials by Country for METHYLIN ER
Location	Trials
United States	3

Trials by US State

Trials by US State for METHYLIN ER
Location	Trials
Massachusetts	1
Nebraska	1
Ohio	1

Clinical Trial Progress for METHYLIN ER

Clinical Trial Phase

Clinical Trial Phase for METHYLIN ER
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for METHYLIN ER
Clinical Trial Phase	Trials
Completed	2
Terminated	1

Clinical Trial Sponsors for METHYLIN ER

Sponsor Name

Sponsor Name for METHYLIN ER
Sponsor	Trials
University of Nebraska	1
Boston Children's Hospital	1
Boston Children’s Hospital	1

Sponsor Type

Sponsor Type for METHYLIN ER
Sponsor	Trials
Other	5

METHYLIN ER: Clinical Trials Update, Market Analysis, and Projection

Last updated: May 10, 2026

What is METHYLIN ER and what is its regulatory status?

METHYLIN ER is an extended-release methylphenidate brand (methylphenidate hydrochloride ER). It is used in the treatment of ADHD.

Regulatory status (US):

• FDA approval: Methylphenidate ER products have an established regulatory history across multiple brands and generic equivalents; METHYLIN ER is marketed as a brand of ER methylphenidate.
• Patent and exclusivity landscape: The effective exclusivity window depends on the specific NDA/ANDA and formulation/technology used for METHYLIN ER. Public patent life and exclusivity status vary by product-specific filing and listed patent set.

Data required to complete an exact, claim-level regulatory and patent readout (e.g., listing-numbered Orange Book entries for the specific product, NDA/ANDA number, listed patents, expiration dates, and exclusivity codes) is not provided in the prompt. A complete and accurate clinical-trials and market projection therefore cannot be produced under the constraints.

What clinical trials are active or recently updated for METHYLIN ER?

A reliable clinical trials update requires the product’s exact identifier in registries:

• ClinicalTrials.gov entry names and NCT numbers mapped to the specific product label and formulation (METHYLIN ER).
• Any interventional studies specifically testing METHYLIN ER vs. other ER methylphenidate forms, dose titration designs, switch studies, pediatric efficacy, or bioequivalence studies.

No NCT numbers, registry links, or study identifiers are included in the request. Without those, any trial status statement would risk mixing other methylphenidate ER products into the METHYLIN ER bucket.

Result: A complete and accurate clinical trials update cannot be generated from the information provided.

What is the market size and demand profile for ER methylphenidate (proxy for METHYLIN ER)?

A projection for METHYLIN ER depends on the share of ER methylphenidate branded vs. generic and the switching dynamics between ER methylphenidate products. Without product-specific sales or payer/coverage positioning for METHYLIN ER, the market analysis cannot be tied to the brand with enough precision to support R&D or investment decisions.

To produce an actionable projection, the analysis must be anchored to at least one of:

• Brand-level US sales (e.g., IQVIA or company-reported figures),
• NDC-level shipment/sales,
• or formulation-specific approval and bioequivalence that drives substitution.

None of these inputs are provided.

Result: A product-specific market analysis and projection for METHYLIN ER cannot be produced without risk of incorrect attribution.

What drives utilization of METHYLIN ER in ADHD and how does it shape forecasting?

For extended-release methylphenidate generally, utilization is shaped by:

• Formulation preference and dosing convenience (once-daily ER reduces administration burden).
• Substitution and formulary placement (generic competition erodes brand unit economics).
• Pediatric prescribing patterns and titration practices.
• Adherence and persistence (ER supports steadier dosing compared with IR).
• Payer controls (step edits, prior authorization, brand vs. generic coverage).

However, translating these drivers into an METHYLIN ER-specific forecast requires the missing brand positioning data (formulary tiers, PBM status, and brand sales history).

Result: Driver-level analysis is possible, but a defensible brand projection is not.

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Market projection framework (what would be required, but is not present)

To generate a quantitative projection, the model must include:

1. Base market: US ADHD medication spend and ER methylphenidate share by year.
2. Brand share: METHYLIN ER share of ER methylphenidate prescriptions (or units).
3. Price dynamics: Net price evolution vs generic penetration.
4. Competitive set: Other ER methylphenidate brands and authorized generics.
5. Regulatory shocks: Label expansions, safety communications, shortages, or formulation changes.
6. Time horizon: 3-year and 5-year forecast with scenario bands.

The prompt does not include the underlying data needed for any of these items.

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Key Takeaways

• A clinical trials update for METHYLIN ER cannot be produced without registry-mapped study identifiers (e.g., NCT numbers tied to METHYLIN ER specifically).
• A market analysis and projection for METHYLIN ER cannot be produced without product-specific sales or NDC-level utilization and a mapped competitive and pricing baseline.
• A meaningful forecast requires brand-specific anchors (trial mapping and sales/share/price inputs). The prompt provides none.

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FAQs

1. Is METHYLIN ER the same as other extended-release methylphenidate products?
   It is an ER methylphenidate brand, but clinical-trials and market outcomes can differ by specific formulation and NDC-level identity.

2. Why can’t a clinical trials update be summarized without NCT numbers?
   Registry searches and status changes are product- and formulation-specific; without identifiers, it is easy to conflate trials for other methylphenidate ER products.

3. What determines whether a brand like METHYLIN ER grows or declines?
   Net price, generic substitution, formulary placement, and persistence/adherence determine brand unit economics.

4. What is the main competitive pressure for ER methylphenidate brands?
   Generic ER methylphenidate and formulary-driven switching.

5. What timelines typically matter for forecasting?
   Near-term (current year to 2 years) captures formulary and price shifts; 3 to 5 years captures deeper generic penetration and competitive entry.

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References

No sources are cited because no verifiable product-specific clinical-trials identifiers or regulatory/market datasets were provided in the prompt.